Table 1.
Baseline characteristics by study cohort
| AZ0001 N=139 | AZ0004 N=191 | EPIC N=46 | Total N=376 | |
|---|---|---|---|---|
|
| ||||
| Male | 68 (48.9%) | 109 (57.1%) | 18 (39.1%) | 195 (51.9%) |
|
| ||||
| Age (years) | ||||
| 6–12 | 18 (12.9%) | 130 (68.1%) | 44 (95.7%) | 192 (51.1%) |
| >12–18 | 59 (42.4%) | 61 (31.9%) | 2 (4.3%) | 122 (32.4%) |
| >18 | 62 (44.6%) | 0 (0.0%) | 0 (0.0%) | 62 (16.5%) |
| mean (SD) | 20.24 (8.379) | 10.76 (3.246) | 8.85 (2.087) | 14.03 (7.398) |
|
| ||||
| Genotype | ||||
| Delta F508 Homozygous | 60 (43.2%) | 87 (45.5%) | 25 (54.3%) | 172 (45.7%) |
| Delta F508 Heterozygous | 42 (30.2%) | 60 (31.4%) | 14 (30.4%) | 116 (30.9%) |
| Other | 6 (4.3%) | 17 (8.9%) | 4 (8.7%) | 27 (7.2%) |
|
| ||||
| Not Done | 31 (22.3%) | 27 (14.1%) | 3 (6.5%) | 61 (16.2%) |
|
| ||||
| Weight (kg) | ||||
| mean (SD) | 53.69 (13.135) | 37.96 (14.435) | 29.93 (8.478) | 42.82 (15.935) |
|
| ||||
| Weight (%)a | ||||
| mean (SD) | 34.08 (27.974) | 43.95 (26.806) | 41.27 (27.429) | 41.07 (27.427) |
|
| ||||
| BMI (kg/m2) | ||||
| mean (SD) | 20.12 (3.105) | 17.87 (2.947) | 17.16 (2.123) | 18.58 (3.135) |
|
| ||||
| BMI (%)a | ||||
| mean (SD) | 39.29 (28.207) | 49.59 (26.231) | 53.43 (25.889) | 47.53 (27.074) |
|
| ||||
| FEV 1 % predicted | ||||
| mean (SD) | 68.23 (20.997) | 98.54 (15.907) | 97.30 (16.628) | 87.10 (23.156) |
a
Weight and BMI percentiles calculated for those subjects ≤ 20 years of age using Center for Disease Control standard equations.